Build it Right and Achieve Compliance

When you make high-stakes products, you need confidence your teams are adhering to compliance or quality processes.

Jama lets teams focus on making great medical devices that drive value and improve quality of life. With Jama configured to your workflows and best practices, teams are empowered to spend more time on product development and less time on managing compliance processes and documentation.

Jama, combined with your organization’s quality process, can facilitate compliance with these regulations: 21CFR820, 21CFR11, ISO 13485, ISO 14971, IEC 62304, IEC 61508

Review and approve robust, contextual information across stakeholders, engineers and partners.

Conduct reviews and approvals

Maintain the chain of approval and increase stakeholder participation. Jama, combined with your organization’s quality process, can facilitate compliance with 21 CFR Part 11.

Design verification and validation

Seamlessly manage V-model traceability including test cases used for verification and validation, and provide evidence to comply with government regulations and standards, like 21 CFR Part 820.

Maintain audit trails with reports

Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including time-stamps and associated users.

Mitigate Risk, Increase Efficiency and Drive Alignment With Traceability

Today, it’s more difficult to innovate while ensuring quality. The rise of software-driven medical devices and the Internet of Things has increased development complexity.

The increased complexity introduces risk to teams using outdated process, like manual traceability. Jama provides intuitive end-to-end linking — including and all related changes, decisions and people — from upstream market and product requirements to test cases and defect tracking.

Construct intuitive rules for traceability.

Trace requirements end-to-end

Link and decompose program-level capability requirements and operational requirements to system requirements, and then down to lower-level software and hardware requirements.

See the impact of change quickly

Fine-grained impact analysis provides instant data insights. Use the analysis to make informed decisions as requirements evolve during long development cycles or due to shifts in technology.

Manage risk analysis

Create a customizable view with calculated fields to manage your risk analysis process within Jama. Ensure that your product is safe and meets regulatory standards.

See it in Action

This five-minute overview illustrates how to use Jama Connect™to build a complex medical device that contains both hardware and software components.

Try Jama Connect for 30 days using the similar datasets by activating your free trial.

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